Department of Clinical Pharmacy, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
Department of Pharmacy, College of Medicine and Health Sciences, Debre Markos University, Debre Markos, Ethiopia.
PLoS One. 2023 Feb 24;18(2):e0282096. doi: 10.1371/journal.pone.0282096. eCollection 2023.
Adverse drug reactions (ADRs) have continued to be a public health challenge with significant clinical and healthcare costs. However, little is known regarding the incidence of ADR in Ethiopia, particularly in the study setting. Thus, this study aimed to assess the incidence and patterns of ADRs in patients admitted to the University of Gondar comprehensive specialized hospital (UoGCSH).
A prospective observational follow-up study was conducted on admitted patients at the medical ward in the UoGCSH from May to August 2022. A multifaceted approach involving daily chart review and patient interviews was employed to collect the data. A standard Naranjo ADR Probability Scale measuring tool was used to characterize the probability of existing ADR. The data was analyzed using the Statistical Package for Social Sciences (SPSS) version 25. Logistic regression analysis was employed to determine the association between the occurrence of ADRs and other variables. A p-value at the 95% confidence interval was considered statistically significant.
This study included 237 participants in total. The average length of follow-up was 16.4 (±5.2) days. Overall, 65 ADRs were identified, resulting an incidence rate of 27.4 (95% CI: 19.8-30.4) per 100 admissions. The most common ADRs were hypokalemia (10.7%), followed by constipation, diarrhea, hypotension, and rash (9.2% each). The majority of these ADRs (73.8%) were classified as "definite" by the Naranjo ADR probability scale. Gastrointestinal tract (GIT) (41.5%) and metabolic (18.6%) were the most frequently exposed systems for ADR. Antibiotics (26.2%) and cardiovascular medications (24.7%) were the most frequently implicated medications in existing ADRs. ADRs were significantly associated with age (p = 0.035), the presence of comorbidities (p = 0.021) and complications (p = 0.008), and receiving a higher number of medications (p = 0.04).
In this study, ADR was identified in about one-fourth of the participants. Older patients, patients with comorbidities and complications, and patients who received a higher number of medications were more likely exposed for ADRs. Healthcare providers should strictly follow the admitted patients to minimize ADRs.
药物不良反应(ADR)一直是一个公共卫生挑战,对临床和医疗保健都带来了重大影响。然而,人们对埃塞俄比亚的 ADR 发生率知之甚少,尤其是在研究环境中。因此,本研究旨在评估在贡德尔大学综合专科医院(UoGCSH)住院的患者中 ADR 的发生率和模式。
本前瞻性观察随访研究于 2022 年 5 月至 8 月在 UoGCSH 的内科病房对住院患者进行。采用多种方法,包括每日病历审查和患者访谈来收集数据。使用标准的 Naranjo ADR 可能性量表来衡量现有的 ADR 可能性。使用社会科学统计软件包(SPSS)版本 25 对数据进行分析。采用逻辑回归分析来确定 ADR 发生与其他变量之间的关系。置信区间为 95%的 p 值被认为具有统计学意义。
本研究共纳入 237 名参与者。平均随访时间为 16.4(±5.2)天。总的来说,共发现 65 例 ADR,每 100 例住院患者中有 27.4(95%CI:19.8-30.4)例发生 ADR。最常见的 ADR 是低钾血症(10.7%),其次是便秘、腹泻、低血压和皮疹(各占 9.2%)。这些 ADR 中有 73.8%(53/71)被 Naranjo ADR 概率量表判定为“确定”。胃肠道(GIT)(41.5%)和代谢(18.6%)是 ADR 最常暴露的系统。抗生素(26.2%)和心血管药物(24.7%)是最常导致 ADR 的药物。ADR 与年龄(p=0.035)、合并症(p=0.021)和并发症(p=0.008)以及接受更多药物治疗(p=0.04)显著相关。
在本研究中,约四分之一的参与者发生了 ADR。年龄较大、合并症和并发症以及接受更多药物治疗的患者更容易发生 ADR。医疗保健提供者应严格监测住院患者,以尽量减少 ADR 的发生。